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The Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM) convened on February 25, 2002, at the Bethesda Marriott Suites, Bethesda, Maryland. Richard Nahin, Ph.D., M.P.H., Executive Secretary of CAPCAM, called the meeting to order at 9:00 a.m.
On this page
- Review of Macrobiotic Best Case Series
- Call to Order, Introductory Remarks, and Meeting Procedures
- Public Comment
- Overview of Rand BCS Project
- Discussion of the RAND BCS Project and Recommendations
- Review of Macrobiotic Best Case Series and Recommendations
- Update on NCCAM Cancer Projects
- Update on OCCAM Cancer Projects
- Adjournment
CAPCAM
Members Present
- Michael Hawkins, M.D., Chair
- Peter L. Choyke, M.D.
- David J. Hufford, Ph.D.
- Lovell A. Jones, Ph.D.*
- Ralph W. Moss, Ph.D.
- Susan K. Quella, R.N.
- David Spiegel, M.D.*
- Douglas L. Weed, M.D., Ph.D.
*via conference call
AD
HOC Members
- Susan Ellenberg, Ph.D.
- Konrad Kail, N.D.
- James E. Williams Jr., Col. (ret)
NIH
Staff Present
- Marguerite Evans, M.S., R.D.
- Richard Nahin, M.P.H., Ph.D.
- Mary Ann Richardson, Dr.P.H.
- Stephen Straus, M.D.
- Jeffrey White, M.D.
Public Present
- Christine Akbar
- Ian Coulter, Ph.D.
- Joan Cunningham, Ph.D.
- Mary Hardy, M.D.
- James Hebert, M.D.
- Larry Kushi, Dr.P.H.
- Jane Teas, Ph.D.
- George Yu, M.D.
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Closed Session - February 25, 2002, 9:00 a.m.-noon
I. Review of Macrobiotic Best Case Series
The morning session was closed to the public for reasons of patient confidentiality in accordance with the provisions set forth in Section 552b(c)(4) and 552b(c)(6), Title 5, U.S.C. and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
Open Session - February 25, 2002, noon-5 p.m.
II. Call to Order, Introductory Remarks, and Meeting Procedures
Richard Nahin, M.P.H., Ph.D., Executive Secretary of CAPCAM, began the open session by asking the Panel members to introduce themselves and noting a change in the agenda. He mentioned the recent death of William Fair, M.D., who had done much in the field of alternative medicine and recently succumbed to colon cancer. This was Dr. Nahin's last meeting as CAPCAM executive secretary. Mary Ann Richardson, Dr.P.H., will take his place.
Stephen Straus, M.D., thanked Dr. Nahin and noted that CAPCAM activities have stimulated work elsewhere. Dr. Straus added that Dr. Fair was an inspiring individual. He will be missed.
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III. Public Comment
Several individuals making public comment were patients from the study presented in the morning's closed session. Identifying information has been removed to protect the identify of the speaker.
The first speaker had extensive cancer. After trying western medicine, the speaker tried a macrobiotic diet and became tumor-free. The speaker is still completely on the diet. In answer to questions, the speaker said that people who are willing to try the diet improve their quality of life if nothing else, though compliance is difficult.
Another speaker had been diagnosed with terminal cancer. The speaker tried conventional medicine, but the cancer returned along with severe pain. The speaker went on the macrobiotic diet, followed it exactly, improved, and recovered.
A third patient from the series spoke. The speaker tried western medicine for cancer and was pronounced in remission, but still felt bad. After beginning the macrobiotic diet, the speaker felt better and said that once one adapts to the diet, it is a delightful lifestyle.
The fourth speaker was a patient not in the series. The speaker's diagnosis was not definitive, which is why the case was not in the series. The speaker had mobility problems, a diagnosis of pancreatic problems that indicated a tumor and lupus. The speaker tried the macrobiotic diet after being given 6 months to live. The speaker continued with conventional medical care during this same period.
The next speaker was Joan Cunningham, Ph.D., of the University of South Carolina in Columbia. She is collaborating with the Kushi Institute to examine the potential impact of macrobiotics on cancer and cancer symptoms. Funding is through the CDC and builds on an Office of Alternative Medicine grant from 1994. The CDC grant is through the special interest programs. Jane Teas, Ph.D., the Principal Investigator on the CDC grant, said that it is a 2-year project with 6 months remaining. The investigators want to learn how people feel when they use macrobiotics, and have interviewed 50 participants about quality of life. They have found that those on the diet have improved their quality of life and have a better sense of well-being. Participants say they regained control over their lives, and developed a sense of hopefulness. They also reported more energy and mental clarity. Dr. Teas thinks the role of macrobiotics should be studied further.
James Hebert, M.D., of the University of South Carolina, was the final speaker. There has been much interest in and use of macrobiotics for cancer. It goes far beyond the scope of a small case series study. The temptation might be to focus on aspects of lifestyle changes, but macrobiotics works synergistically, so it should not be disassembled for study purposes. Randomization might be difficult or impossible, but that should not prevent funding of studies.
Further discussion ensued. In answer to a question, Ms. Christine Akbar of the Kushi Institute said that she believed that Micho Kushi Institute charged $800 for an individual first visit, and $900 for a family with no limits on size; the consultation fee is lower and varies for other Kushi Institute staff. Dr. Kushi reminded the Panel that the cases from the morning were selected from 77 compiled under the original OAM grant. These were the cases for which information could be gathered. In answer to another question, Dr. Kushi noted that there were at least a couple of situations in which third parties (insurers) paid for the patients to go to the Institute.
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IV. Overview of Rand BCS Project
Ian Coulter, Ph.D., and Mary Hardy, M.D., presented an update on the RAND Best-Case Series (BCS) Project. The aim of the project was to help CAM cancer providers create a best case series, and to determine if the evidence justified further study. NCCAM identified two CAM providers for participation in the RAND project. These CAM providers, in turn, identified their best cases for RAND staff. RAND personnel visited the practices, looked at files, and interviewed patients. As part of the patient interview, subjects completed a quality-of-life interview, and helped confirm and complete incomplete medical records. RAND sought proof of conventional care, documentation of the CAM therapy, the dates of CAM therapy, a documented end point, and a documented diagnosis. Patient consent was critical. One of the greatest challenges was from RAND's own Institutional Review Board.
The first treatment RAND investigated was the Immuno-Augmentation Therapy (IAT). RAND reviewed 300 patient cards, found 58 cases to examine further, rejected 40 of these, accepted the remaining 18, and selected 9 to study in depth. There were many reasons for rejection, with lack of record retention being a substantial problem. Three years seems to be the most common length of record retention now. In general, this clinic had, to the extent possible, the necessary documentation for compiling a BCS.
The other best case series dealt with naltrexone as used to treat persons with cancer. RAND found 23 cases at the provider's clinic, rejected 2, did case reports on 10 of the remaining 21, and selected 3 for in depth study. Records are pending in two cases, and hard to find in the third. There was extensive use of other therapies at this clinic. The challenges faced by RAND staff included the number of patients, the fact that the clinic was not the primary provider, the fact that the treatment was used as adjunctive therapy, substantial confounding by other therapies, incomplete medical records, lack of established informed consent procedures, and recent treatment (absence of long-term survival data).
Dr. Coulter said that in retrospect, RAND identified several key issues that impeded completion of the project in a timely fashion: 1) picking sites without complete patient records; 2) problems obtaining and maintaining records; 3) inadequate on-site resources for collating and abstracting case documentation; 4) slow informed consent process; and 5) the BCS Catch-22--if the subjects do not survive, they are not candidates, but if they survive, it is likely their records no longer exist.
Dr. White suggested that in his opinion, the BCS Catch-22 does not exist as Dr. Coulter described it. Instead Dr. White felt that while some data are not available, most is, even if it is difficult to obtain.
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V. Discussion of the RAND BCS Project and Recommendations
Konrad Kail, N.D., expressed frustration that despite RAND's best efforts, there was still not enough documentation for a full presentation to CAPCAM. He questioned the need for all the current NCI BCS requirements and suggested that evaluation of prospective (vs. retrospective) case series would, in general, be better use of everyone's time and effort (i.e., RAND, CAM practitoner, NIH staff, CAPCAM). David Hufford, Ph.D., agreed that prospective studies were the best way to go. Dr. Nahin asked members how they would choose which therapies to put into prospective studies. He added that the current best case series approach was designed as a way to identify promising therapies for further study. Michael Hawkins, M.D., said that the idea behind the best case series was to move the debate from anecdotes to the next step. Susan Ellenberg, Ph.D., added that some prospective studies might not turn up anything for years.
Dr. Straus stated that NIH now supports more than 200 CAM studies at both CAM and conventional institutions. To get NIH funding, these institutions have to show they can accomplish the proposed work. Dr. Nahin added that, on the other hand, the best-case process is for treatments with a limited scope and extravagant claims, which are usually practiced outside of an academic setting (either CAM or conventional). CAPCAM was created to identified these treatments. Dr. Hawkins suggested that NIH could set up a resource for practitioners to prospectively register their patients. If patients consented to be monitored, the practitioners could turn monitoring over to someone at NIH/NCI. David Speigel, M.D., asked about looking for extreme cases. Jeff White, M.D., said that NCI has thought about this. There is the expectation that some cancers are uniformly lethal. However, even in these types of cancer, some patients survive. In order to decrease the potential for selection bias, the best case series is designed to evaluate tumor response rather than survival.
Dr. Straus asked for the panel's advice on the viability of the best case series. Dr. White said that he believes the BCS is important and that NCI is willing to provide more support for the process if necessary. Dr. Hufford said that it would be precipitous to give up at this point, though it is frustrating. He believes the BCS process has had a positive effect on the practitioner-researcher community. Dr. Choyke added that the BCS is a needed entry point for practitioners and is a useful pre-screen.
Douglas Weed, M.D., Ph.D., said he thought the purpose of the best case series was to identify new treatments in isolated clinics. The RAND study shows that small clinics cannot do this work themselves. Dr. Kail suggested that it would be helpful for independent CAM researchers to collaborate with other researchers who have the necessary research infrastructure. Dr. Ellenberg reiterated that the point of the effort is to identify what does and does not work. Dr. Hufford added that despite the frustrations, they should keep in mind that having cases that fail is nonetheless consistent with good results. Yet it must be remembered that failures are not contrary evidence to a claim, they are the absence of support.
Dr. Coulter observed that the next challenge is to choose between the more retrospective method RAND used or a prospective method. Dr. Hawkins said that he found the presentation to be very sobering and was unsure about the next step. He did not want to stop the best case series. However, he felt that based on what CAPCAM has seen to date, there is no reason to believe that they will get good information from the BCS as things now stand. Perhaps a solution might be to put resources toward a prospective data system. Dr. Hawkins suggested that it would be useful for CAPCAM to see the RAND data. Dr. Nahin said that it would be unfair to bring forward cases that are not ready or that are likely to fail CAPCAM's minimal standards. Dr. Choyke observed that perhaps practitioners need to be better educated. Dr. Speigel wondered about identifying practices, bringing practitioners in, and training them to do research. Dr. White said that NIH could provide CAM practitioners with data management and other skills and get them in contact with physician-based research networks and groups.
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VI. Review of Macrobiotic Best Case Series and Recommendations
Dr. Hawkins briefly reviewed the morning's proceeding for the audience. He explained that the closed session had been a best case series presentation by Larry Kushi, Dr.P.H., of Kaiser Permanente, George Yu, M.D., of George Washington University, and Ms. Christine Akbar of the Kushi Institute. The presentation was a retrospective examination of six cases involving patients with various malignancies treated using the macrobiotic approach of Michio Kushi. Dr. Kushi, Dr. Yu, and Ms. Akbar presented data showing documented instances of patient survival but there was, in general, insufficient evidence of tumor regression. The Panel's task was to identify cases in which they could tease out the role of the macrobiotic diet from other influences. The Panel was generally enthusiastic about the best case series presentation, but were disappointed in the lack of supporting radiographic evidence (but understood the difficulties in obtaining this material). After reviewing the presented cases, the Panel judged that in two of the six cases, the patients on the macrobiotic diet survived longer then expected, but that the other four cases were not convincing.
Dr. Kail noted that a significant number of people use the macrobiotic diet. He wanted to create a mechanism for selecting the best cases prospectively. He observed that change occurred quickly, always within a year, so patient follow-up would not be extravagent. Dr. Hawkins suggested a grant to have someone work full-time to track down the documentation. Dr. Hufford wondered about the ability of the Kushi Institute to prognosticate. Ms. Quella said that she would like to see a formal clinical trial. Dr. Hawkins said that it would be difficult to randomize. Dr. Ellenberg added that they should first have a prospective series for background support. She wondered whether there might be specific oncologists interested in this area, who could be connected with a macrobiotic clinic, thus assuring the needed documentation.
Dr. Choyke said there would be logistical difficulty in a trial based on diet. There would have to be cooks involved, which is atypical. Dr. Straus said that they will need to study the diet as it is practiced, not in an overly standardized form. Dr. Choyke suggested that they could standardize the practice nonetheless. Dr. Hawkins thought they should start with a pilot of about 30 patients. Compliance is difficult in a large trial. The Pilot would help better identify what really happens with the patients. Dr. Weed argued that a clinical trial is a goal, but they are not yet ready for one. While a prospective study is a small step, it is where they should go at this point. Dr. Hawkins suggested that such a study could collect data on treatment, compliance, and outcomes. Several members of CAPCAM stated that any prospective studies of macrobiotics should study the diet as commonly practiced and allow for some degree of individualized practice.
Dr. Nahin asked for a motion. Dr. Hufford moved that they recommend to NCI and NCCAM that the study of macrobiotics be taken to the next step, possibly a prospective study. The motion was seconded and passed unanimously.
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VII. Update on NCCAM Cancer Projects
Mary Ann Richardson, Dr.P.H., described the current state of NCCAM cancer projects. Funding for cancer research has increased. About 12 percent of NCCAM funding goes to cancer-related studies. In terms of funding mechanisms, there are 10 R01s, 16 R21s, and 40 grants altogether for a total of 53 projects, which is more than double the number in May 2001. In the area of botanical/drug interactions, NCCAM has funded nine projects, four of which are for cancer. There are also five university-based programs, including one at Johns Hopkins University. A U10 cooperative clinical trial funded with NCI looks at the prevention of prostate cancer with dietary supplements. This trial, of 36,000 African American men, will follow participants for 7 to 12 years, at a total cost of $120 million. Following a previous CAPCAM recommendation, NCCAM is also trying to launch a study of "Sun soup," which contains purported antitumor and immune boosting foods. Small trials have suggested improved survival and quality of life using "Sun soup." Dr. Sun is now collaborating with well-regarded conventional trialists from Mt. Sinai Hospital in New York. NCCAM is also looking at antioxidant supplements as used with chemotherapy and radiation. The Center will have a state of the science workshop on antioxidants in the near future.
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VIII. Update on OCCAM Cancer Projects
Dr. White discussed the NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) program. The practice assessment program deals with best case and practice outcomes monitoring. The number of best case series submissions have grown dramatically, from fewer than 2 submissions in 1999 to 9 in 2001. Promotion for the best case series continues, with ads in various publications. The ad that has generated the most inquiries was in the journal, Alternative Medicine: The Voice of Health. Dr. White introduced two new staff members. Colleen Lee, R.N., is OCCAM's coordinator of the Practice Assessment Program with day-to-day responsibility for the BCS program. Anne Washburn, M.P.H., is developing materials for summaries, fact sheets, and the Web site. New PDQ summaries are being drafted.
Joint initiatives with NCCAM include the funding of five CAM projects at NCI Cancer centers, with OCCAM funding a sixth on it own. Projects funded include those investigating botanicals, mind-body interventions, and CAM systems. Large clinical trials cover such treatments as liquid shark cartilage, powdered shark cartilage, and the Kelley/Gonzalez regimen. Per previous CAPCAM recommendations, NCI continues to work with the P. Banerji Homeopathic Research Foundation in Calcutta. The Foundation and NCI have a verbal agreement, along with a written protocol. NCI is working on obtaining IRB approval, internal scientific clearances, and a contract for data gathering. There is still some work to do before the study begins.
IX.
Adjournment
As there were no comments or new business, the meeting adjourned.
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